Sufentanil Viatris Solution

What SUFENTANIL VIATRIS is: SUFENTANIL VIATRIS is a type of medicine called an opioid analgesic. The word opioid means a substance similar to opium, for instance strong pain reliever. An analgesic is a medicine that can be used to relieve pain.

What it is used for:

• SUFENTANIL VIATRIS is used to provide pain relief during surgical procedures and operations.
• SUFENTANIL VIATRIS is also used to provide pain relief in patients whose breathing must be assisted during surgery.
• SUFENTANIL VIATRIS is administered by epidural route for:
• Post-operative pain management following general surgery, thoracic or orthopaedic operations and Caesarean sections.
• As an analgesic adjunct to epidural bupivacaine with or without epinephrine (adrenaline) during labour and vaginal deliveries.

You or your child should not be administered SUFENTANIL VIATRIS:

• If you or your child are hypersensitive (allergic) to sufentanil or any of the other ingredients of SUFENTANIL VIATRIS.
• If you or your child have previously had a hypersensitive (allergic) reaction to other strong pain relievers.
• If you are pregnant or breastfeeding.
• If you or your child have medical conditions such as severe bleeding or shock, blood poisoning, infection at the site of the injection, blood disorders where the epidural administration of SUFENTANIL VIATRIS cannot be used e.g. if you are taking an anticoagulant (a medicine used to prevent the formation of new blood clots).
• The safety and efficacy of epidural SUFENTANIL VIATRIS in children younger than 1 year have not been established.
• In order to avoid possible breathing problems in the newborn baby due to the medicine, SUFENTANIL VIATRIS should not be injected into a vein (intravenous use) during labour or during a caesarean section if the umbilical cord has not yet been cut. Injection around the spinal cord (epidural use), however, is safe for the newborn.
• If you or your child are taking, or has taken, monoamine oxidase inhibitors (MAOIs) used for depression, in the last 2 weeks.

Warnings and precautions

Special care should be taken with SUFENTANIL VIATRIS: Tell your doctor or healthcare professional before being administered SUFENTANIL VIATRIS if you or your child:

• Have breathing disorders or a lung disorder, such as asthma, bronchitis or emphysema. SUFENTANIL VIATRIS may weaken breathing. This may also occur sometime after the operation.
• Have any kind of heart disease (for instance heartbeat abnormalities, heart blocks or inadequate blood supply to the heart).
• Have blood pressure that is abnormally low.
• Have a problem with blood circulation in your brain.
• If you are elderly or weak due to ill health.
• Have a thyroid gland deficiency.
• Have a history of alcohol abuse.
• Have liver or kidney disorders.

• Do not share medicines prescribed for you with any other person.

• You will not be expected to give yourself SUFENTANIL VIATRIS. It will be given to you by a person who is qualified to do so.

• SUFENTANIL VIATRIS is given intravenously or as epidural administration.

• Your doctor will work out the dose of SUFENTANIL VIATRIS that you will need based on your age, weight, physical condition and other medicines that you are taking.

• If you have the impression that the effect of SUFENTANIL VIATRIS is too strong or too weak, tell your doctor or pharmacist.

If you receive more SUFENTANIL VIATRIS than you should: Since a doctor will administer SUFENTANIL VIATRIS, it is unlikely that you will be given too much, as he/she will control the dosage.

SUFENTANIL VIATRIS can have side effects. Not all side effects reported for SUFENTANIL VIATRIS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SUFENTANIL VIATRIS, please consult your healthcare provider for advice.

If any of the following happens, stop taking SUFENTANIL VIATRIS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing (abnormally slow and/or weak breathing or temporary cessation of breathing);
• skin rash, irregular skin patches and itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SUFENTANIL VIATRIS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Slow or absence of a heartbeat;
• chills or shivering or fever;
• feel dizzy, lightheaded, faint, very tired or weak, drowsy, confused;
• spasm of the breathing passages and vocal cords;
• cardiac or respiratory arrest, disease in the electrical system of the heart (atrioventricular block), abnormal electrocardiogram;
• insufficient blood flow to the body tissues (shock), bluish discolouration of the skin or mucous membranes caused by lack of oxygen in the blood (including that of newborn);
• coma.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Headache;
• constipation;
• dry mouth;
• nausea, vomiting;
• sleepiness, a state of calm, lack of interest;
• neonatal tremor (jitters or trembling of the arms and legs);
• pale appearance;
• sudden muscle twitches;
• loss of bladder control.

The following side effects have been reported less frequently:

• Feeling of intense happiness, perception of hearing and seeing things, mood changes;
• abnormal thinking, feeling anxious, sense of well-being, nervousness, problems with co-ordination, sensation of whirling and loss of balance, restlessness, loss of body temperature below normal;
• abnormal vision; visual disturbance, small pupils;
• abnormally rapid or irregular heartbeats;
• low or high blood pressure;
• stop of breathing for a short period of time;
• facial flushing, sweating;
• muscle stiffness, repetitive body movements/muscle twitching;
• difficulty passing urine;
• hiccups;
• sneezing, itching, nasal discharge and congestion;
• pain, including back and injection site pain, and injection site reactions;
• excessive sweating, redness of the skin, rash (including of newborn), dry skin, discoloured skin;
• mild sleepiness may occur after administration around the spinal cord (epidural use).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

By reporting side effects, you can help provide more information on the safety of SUFENTANIL VIATRIS.

Store all medicines out of reach of children.

Store at or below 25 ° C.

Keep the container in the outer carton until required for use.

Protect from light.

Do not store in a bathroom.

Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

For single use only or discard unused portion after initial opening.